Bei Daiichi Sankyo stehen wir vereint hinter einem einzigen Ziel: Das Leben auf der ganzen Welt durch innovative Medikamente zu verbessern. Mit aktiver Innovation seit 1899, Präsenz in mehr als 30 Ländern und über 19.000 Mitarbeitern entwickeln wir bahnbrechende Therapien in der Onkologie, für Herz-Kreislauf-Erkrankungen, seltene Krankheiten und Immunerkrankungen. Im Einklang mit unserer Vision 2030, "ein innovatives globales Gesundheitsunternehmen zu sein, das zur nachhaltigen Entwicklung der Gesellschaft beiträgt", gestalten wir eine gesündere, hoffnungsvollere Zukunft für Patienten, ihre Familien und die Gesellschaft.
The Position:
The Quality Expert – Daiichi Sankyo EU Affiliate Support will be responsible to provide operative support to the local QA Managers of a defined country cluster. In addition, he will support the local Responsible Persons according to the European GDP Guideline.
Roles and Responsibilities
- Registration and follow-up of complaints, returns, deviations, changes, and CAPAs
- Support the Quality Manager/RP in updating GxP-relevant SOPs
- Management and administration of trainings
- Support of customer qualification activities
- Participation in self-inspections
- Assist in preparation of annual management review
- GDP product release support
- Support of country-specific QA projects
- Deputize local Quality Manager/RP
Personal Skills and Professional Experience:
- University/FH/Master's degree in natural or pharmaceutical sciences, preferably in Pharmacy, Chemistry, or a comparable program
- At least 2 years of relevant work experience in the pharmaceutical industry in Quality Assurance and/or Quality Management
- Knowledge of European GMP/GDP regulations
- Team player with high quality consciousness, accurateness, reliability, and a solution-oriented mindset
- Very good written and verbal communication skills in English; additional European languages (e.g. Italian, Spanish, French) are an advantage
